Transportation of Medical Instruments

ABSTRACT

A device ( 2 ) for the transportation and temporary storage of a medical instrument such as an endoscope ( 4 ) comprises: an instrument bag ( 6 ) formed of a plastics material substantially impermeable to bodily fluids, the bag having an opening ( 8 ) for receiving the instrument; an inner label ( 10 ) which has a first portion ( 12 ) adhered to an external surface of the bag adjacent to the opening ( 8 ) and has a second portion ( 14 ) which is disposed beyond the opening  98 ) and which has a lower surface which is adhesive and covered by a removable backing and an outer label ( 16 ) which overlies the inner label ( 10 ) and which has a first portion ( 18 ) which has a lower surface adhered to at least one of an external surface of the bag ( 6 ) and an upper surface of the inner label ( 10 ), and a second portion ( 20 ) which is disposed beyond the opening ( 8 ) and which has a lower surface at least part of which is adhesive and covered by a removable backing ( 24 ).

FIELD OF THE INVENTION

The present invention relates to a device for the transportation andtemporary storage of medical instruments such as endoscopes in a medicalfacility.

BACKGROUND TO THE INVENTION

Endoscopes are used for the internal examination of the human or animalbody. They are produced in a range of lengths and diameters depending onthe intended use. Typically, an endoscope is flexible, and may have aninternal channel, or lumen, down which fluids may be directed. Becauseof the invasive nature of endoscopy, it is necessary that an endoscopebe thoroughly cleaned and disinfected after use on a patient before itis used for another procedure. After use, the endoscope undergoes adecontamination procedure involving cleaning, disinfecting andsterilising prior to re-use. WO 2005/107823 discloses a decontaminationsystem which provides cleaning wipes to remove organic deposits,disinfectant/sterilising wipes and sterile rinse wipes to removedisinfectant residues. Each wipe is typically provided in its own sealedsachet which may provide information such as lot or batch number, dateof manufacture and expiry date. This information may be transferred to arecord book as part of an audit trail to provide a record that aninstrument has been properly decontaminated and the date on which thiswas done.

Each sachet may also optionally be provided with a data carrier such asa bar code or RFID tag, and corresponding data carriers may be providedfor the instrument to be decontaminated and for patient and operatordetails. When carrying out a decontamination procedure, each datacarrier is read and a print-out may be produced which providesconfirmation that the decontamination procedure has been carried out inaccordance with correct procedure, and optionally details such as theinstrument decontaminated, the operator, and data specific to a patient.These systems facilitate the provision of proper audit trails to ensurethat an instrument is known to have been decontaminated in accordancewith procedure.

Ideally, the decontamination procedure is carried out in close proximityto where the endoscope will be used, and preferably immediately beforeit is to be used. However, such ideal conditions seldom occur.Typically, a decontaminated instrument must be temporarily stored untilrequired, and it may need to be used in a procedure room which is somedistance from where decontamination took place.

For transportation of endoscopes before and after use, it has beenproposed in WO 2003/034936, to provide a re-usable tray having anendoscope compartment, a single-use disposable tray-liner having anopen-faced pouch, and a pouch-closing protective cover. The tray-lineris impermeable to body fluids, and flexible enough that the pouch isable to conform to the contours of the endoscope compartment. When anendoscope is placed in the pouch within the endoscope compartment, theprotective cover can be detachably extended across the open face of thepouch from one edge to another so as to enclose and protect theendoscope.

To provide traceability data, an operator may place a ticket carryingthe data in the tray, under the tray-liner. A problem with this is thatit is necessary to remove the protective cover and the tray-liner toaccess the traceability data. Movements in the course of this operationgenerate particles and increase the risk of contamination. Analternative, in which a ticket is placed on the instrument itself, alsointroduces an undesirable source of potential contamination.

Another transportation system provides two large instrument bags: onefor decontaminated endoscopes and the other for contaminated endoscopes.The two bags may be of different colours to allow easy differentiation.However, the action of unfolding the bags is also liable to generatepotentially contaminating particles.

SUMMARY OF THE INVENTION

According to the present invention there is provided a device asspecified in claim 1. Preferred features are specified in the dependentclaims.

The invention provides an instrument bag that is easily sealed, ensuringno harmful organisms compromise the sterility of the decontaminatedmedical device. Contaminated instruments are kept in an enclosedenvironment, protecting healthcare staff from transmission ofpotentially harmful pathogens.

The invention also provides for traceability data to be transportedalong with the medical device, ensuring that patient and instrumentrecords are always linked.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be further described, by way of example, withreference to the following drawings in which:

FIGS. 1 and 2 show a device in accordance with an embodiment of theinvention, with the inner label respectively concealed and revealed;

FIG. 3 is a schematic view of part of the device of FIG. 1;

FIGS. 4 and 5 are plan views showing respectively an outer label and aninner label for use with a device in accordance with an embodiment ofthe invention;

FIGS. 6 to 14 illustrate stages in the use of a device in accordancewith another embodiment of the invention; and

FIG. 15 is a view similar to FIG. 6 of a further embodiment of theinvention.

DETAILED DESCRIPTION

The device 2 shown in FIG. 1 provides transportation and temporarystorage for a medical instrument such as an endoscope. The device 2comprises an instrument bag 6 which has an opening 8 for receiving theinstrument. The bag 6 is formed from a plastics material which isimpermeable to bodily fluids so that a user is protected frompotentially harmful pathogens that may be present on a contaminatedinstrument sealed within the bag 6. The bag 6 has an inner label 10(FIG. 2) and an outer label 16. In this embodiment, the inner label 10is adhered to an external surface of the bag 6 adjacent to the opening8. The outer label 16 overlies the inner label 10 and has a firstportion 18 which has a lower surface adhered to at least one of anexternal surface of the bag 6 and an upper surface of the inner label10. The outer label 16 has a second portion 20 which is disposed beyondthe opening 8 and which has a lower surface at least a part of which isadhesive and covered by a removable backing.

Referring now to FIG. 3, a partial x-ray view of an embodiment of theinvention shows the inner label 10 comprising a first portion 12 adheredto an external surface of the bag 6 adjacent the opening 8, and a secondportion 14 which is disposed beyond the opening 8. The second portion 14has a lower surface which is adhesive and covered by a removablebacking.

The first portion 18 of the outer label 16 in this embodiment includes afirst region 26 which does not have an exposed adhesive lower surfaceand which extends to an edge 46 of the outer label 16, and an area 22which has an adhesive lower surface which is adhered to the surfacebeneath and which in this example, is generally L-shaped.

The second portion 20 of the outer label 16 in this embodiment includesa second region 28 which does not have an exposed adhesive lower surfaceand which extends to an edge 46 of the outer label 16. The lower surfaceof the second portion 20 of the outer label includes an area 24, whichin this example is generally L-shaped. Area 24 has a lower surface whichis adhesive and covered by a selectively removable backing. Thissurface, when exposed, allows a user to seal the bag 6.

The first region 26 and the second region 28 define a pocket 30 (bestshown in FIG. 11) for receiving a data carrier 32 such as a disinfectantwipe sachet or a printed ticket carrying traceability information, whenthe exposed adhesive surface of the second area 24 of the outer label isadhered to an external surface of the bag. It will be appreciated thatthe pocket could alternatively be provided solely by the first region 26in an alternative embodiment.

Examples of an outer label 16 and an inner label 10 are shown in FIGS. 4and 5 respectively. The outer label 16 has an upper surface 36 whichcarries information denoting that the contents of the bag are clean. Theinner label 10 has an upper surface 34 that carries information denotingthat the contents of the bag are contaminated.

Referring now to FIGS. 6 to 14, steps in the use of a device inaccordance with an embodiment of the invention are as follows. Eachinstrument bag 6 may be provided in its own outer bag 38 which is formedof a fluid-impervious material and is sealed to prevent ingress ofcontaminants.

The instrument bags 6 may be sterilised by gamma-irradiation eitherbefore or after insertion in the outer bag 38.

The sealed outer bags containing the instrument bags are provided, inthis example, in boxes 40.

When a decontaminated instrument is to be transported to a theatre ofuse, the user removes one outer bag 38 and its contents from the box 40(FIG. 6).

The user cuts the short edge of the outer bag 38 with a cuttingimplement 42, allowing the contents to be accessed (FIG. 7).

The user removes the instrument bag from the outer bag 38 by pulling thefree second portion 20 of the outer label 16 (FIG. 8). The outer bag 38may now be disposed of.

Still holding the second portion of the outer label, the user holds theinstrument bag 6 open with minimal contact and inserts the clean medicaldevice 4, which in this example is an endoscope (FIG. 9).

The L-shaped backing 24 is peeled off the second portion 20 of the outerlabel, and the instrument bag is sealed by pressing of the exposedadhesive portion onto an outer surface of the instrument bag (FIG. 10).

The user then places a data carrier 32 into the pocket 30. In thisexample the data carrier is a sachet of the sporicidal wipe used todisinfect the medical device 4 such as is described in WO 2005/107823;it will be understood that other data carriers may be used which willprovide appropriate traceability information. Such information mayinclude, but is not limited to, patient notes, instrument records, lotor batch number of the disinfectant used on the instrument, use-by dateof the disinfectant. The medical device 4 is now ready for safetransport to the next patient, together with traceability data relatingits disinfection (FIG. 11).

When the instrument is to be used (FIG. 12) medical professional seesthat the instrument is clean and takes out the data carrier 32. Theinstrument bag 6 is opened by peeling off the outer label 16, which maythen be discarded. The clean seal is now broken and the inner label 10is revealed (FIG. 12). The clean instrument 4 is removed from theinstrument bag 6 for use (FIG. 13) but the bag 6 is retained.

After use, the contaminated instrument 4 is placed back in theinstrument bag 6. It is preferred that the opening of the bag is sealed,and in this embodiment, the inner label has a free second portion 14with an adhesive lower surface and a removable backing 44. The userpeels off the backing 44 and reseals the bag 6 with the contaminatedinstrument 4 within it (FIG. 14). The instrument 4 is now ready for safetransport to the decontamination room.

In the embodiment of FIG. 15, the optional outer bag is omitted. Theinstrument bags 6 are sterile (in this embodiment, having beensterilised by gamma-irradiation) and are packed in a box 40.Sterilisation may conveniently be carried out by gamma-irradiation onthe devices when packed in the box. A user can remove the devices inturn as required by gripping and pulling on the outer label 16. Furthersteps are as illustrated with respect to FIGS. 9-14.

It will be appreciated that various sizes of instrument bag may be useddepending on the size of the instruments they are to contain.

The terms “upper” and “lower” and the like are relative and to beconstrued having regard to the context of the described embodiments.

The articles “a” and “an” are used herein to mean “at least one” wherethe context permits.

1. A device for the transportation and temporary storage of a medical instrument such as an endoscope, the device comprising: an instrument bag formed of a plastics material substantially impermeable to bodily fluids, the bag having an opening for receiving the instrument; an inner label which has a first portion adhered to an external surface of the bag adjacent to the opening and has a second portion which is disposed beyond the opening and which has a lower surface which is adhesive and covered by a removable backing; and an outer label which overlies the inner label and which has a first portion which has a lower surface adhered to at least one of an external surface of the bag and an upper surface of the inner label, and a second portion which is disposed beyond the opening and which has a lower surface at least part of which is adhesive and covered by a removable backing.
 2. A device according to claim 1, wherein the lower surface of the first portion of the outer label has a first region which is not adhered to the surface beneath and which extends to an edge of the outer label.
 3. A device according to claim 2, wherein the lower surface of the second portion of the outer label includes an area which has a selectively removable backing to provide an exposed adhesive surface and a second region which does not have an exposed adhesive surface and which extends to an edge of the outer label.
 4. A device according to claim 3, wherein the first region and the second region together define a pocket for receiving a data carrier when the outer label is adhered to an external surface of the bag.
 5. A device according to claim 3, wherein the selectively removable backing is generally L-shaped.
 6. A device according to claim 1, wherein the adhesive lower surface of the first portion of the outer label is generally L-shaped.
 7. A device according to claim 1, wherein the inner label has an upper surface which carries information denoting that the contents of the bag are contaminated.
 8. A device according to claim 1, wherein the outer label has an upper surface which carries information denoting that the contents of the bag are clean.
 9. A device according to claim 1, further comprising an outer bag which contains the instrument bag, the outer bag being formed of a fluid-impervious material and sealed to prevent ingress of contaminants.
 10. A device according to claim 1, wherein the lower surface of the first portion of the outer label has a first region which is not adhered to the surface beneath and which extends to an edge of the outer label and defines a pocket for a data carrier. 